An interview with Jerry Avorn

Jerry Avorn's new book, Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs, provides insight into one of the central medical debates of our time: how to ensure that prescription drugs are affordable, effective and safe. Avorn, a physician and associate professor of medicine at Harvard Medical School, uses case studies, research and his own experiences to mount a critique of the pharmaceutical industry. With the costs of prescription drugs soaring and concerns about the safety of drugs growing almost daily, Avorn seeks in this book to find a cure for the nation’s pharmaceutical ills.

Assistant editor Amos Esty asked Avorn to talk about his findings, his proposed solutions and the experience of writing Powerful Medicines.

What inspired you to write this book? What did you hope to accomplish? Do you feel you were successful?

I've always been struck by the mismatch between the knowledge that's out there about drug effects, safety and cost-effectiveness on the one hand, and patterns of actual prescribing and drug-taking on the other. It seemed important to write about how wide that gap is and to propose some practical things we can do to narrow it—as doctors, as patients and as a nation. I hoped to spur debate about how we could do a better job of getting the right drugs to the patients who need them, at an affordable cost. All in all, I'm pleased with how the book came out. It covered all the bases I had hoped to cover, although of course new issues seem to arise every week.

Your book details an immense number of problems with the prescription drug industry. What would you say are the greatest threats posed to the American public by the current state of affairs?

The first big problem is that we don't require that new drugs be tested against existing ones to compare their effectiveness or safety, not to mention their relative economic value. That leaves huge gaps in the knowledge base that doctors and patients can draw on in making decisions about what to prescribe or take.

The second major problem is our inability to track a drug's side effects adequately, either before or after its initial approval by the U.S. Food and Drug Administration [FDA]. The recent revelations about antidepressants and suicide in adolescents, or Vioxx and heart attack, are two amazing examples from a single recent month. We have a major problem in regulation and science policy here.

A third problem is the unaffordability of prescription drugs for so many patients. It's unacceptable for us to be the only industrialized country that doesn't ensure that all of its citizens have access to the medicines they need.

You criticize the notion that the free market can cure our health care crisis, yet you also seem skeptical of the ability of the government to tackle these issues. What do you see as the proper role of government in health care and pharmaceutical reform?

There are a few areas in which the government is indispensable. First is its public health role in making sure that all drugs on the market are safe and effective. We've seen recent evidence that the Food and Drug Administration has failed in this regard for two of the most commonly used drug groups: antidepressants like Paxil and Zoloft in young people, and analgesics like Vioxx. We shouldn't "outsource" this kind of research to the pharmaceutical companies with so little regulatory oversight. For nonprescription drugs, a very bad 1994 law took most "supplements" and herbal preparations out of the FDA's jurisdiction and opened the door to the horribly misleading ads and claims we see so frequently today for these products.

The second crucial role for government is to make sure that every citizen has the capacity to pay for needed medical care, and that includes drugs. I'd favor a model in which each citizen has a voucher for health insurance and gets to spend that voucher in any one of several comprehensive health care systems—ideally, nonprofit ones that can't prosper by denying sick people needed care.

Efforts at reforming the drug industry, such as the Kefauver Act (a 1962 law that required that drugs be proven effective before being approved), and the withdrawal of harmful drugs from the market, such as Rezulin (a drug for diabetes that caused dozens of deaths), have often succeeded in large part because they followed on the heels of a tragedy. Do you think it will again take some type of disaster before serious reforms can be made?

Time will tell whether the recent revelations about Vioxx and antidepressants will be the crises that prompt reassessment of how we regulate and approve drugs. It's unfortunate that we seem to need high-profile tragedies to trigger needed improvement in our drug policies, but perhaps some good may come from these problems as a result. Most of all, we need to get over the brainless belief that when it comes to human services, "government is the problem." It isn't.

Some drug companies, including Merck and GlaxoSmithKline, have recently announced that they will soon begin posting all their test results to the Internet. The governor of Illinois has also recently announced that his state will begin helping residents purchase cheaper prescriptions from Canada and some European countries. Do these seem like steps in the right direction? Is progress being made?

Yes and no. Posting the results of clinical trials on the web will be helpful, but we need to remember that advertising and promotion to patients as well as doctors will still drive prescribing more than information on the Internet does. We'll still need to redress the imbalance of hype over science in what gets communicated to prescribers and consumers. I suggest several ways this could be accomplished in Powerful Medicines.

As for the Canadian drugs solution, it will be a short-term quick fix for many Americans who can't afford to buy the medicines their doctors prescribe for them at U.S. prices. But we also need more fundamental solutions: more reasonable prices for drugs bought here at home, as well as more cost-conscious prescribing by doctors.

You propose setting up a new "information transfer system" that would provide doctors with information about drugs that would not be sponsored or created by drug companies. What are the major obstacles to creating such a system?

We're actually seeing a proliferation of such "academic detailing" to provide doctors with a noncommercial source of drug information; new statewide programs using this approach are getting off the ground in Pennsylvania and Kentucky, as well as in health care systems throughout the country. As with any innovation, the major obstacle has been inertia—not knowing who would sponsor such programs or how they would be paid for. With the dramatic rise in the cost of medications and growing concern about the need to get the best information to doctors as quickly and impartially as possible, these barriers are beginning to break down.

You are very critical of the notion that doctors can take gifts and free samples without it affecting their ability to prescribe objectively. Should there be no contact between drug companies anddoctors? Is it inherently unethical for leading doctors to sit on the boards of pharmaceutical companies or be paid to give talks about their products?

Many people are surprised to hear that I don't favor a ban on contact between doctors and drug sales reps, even if we could accomplish that (which would be nearly impossible to do). What we do need are more noncommercial information sources for doctors and patients about how best to choose among the many drug products out there. When we've offered such informational outreach to doctors, they have preferred it to the sales pitches they get from people trying to sell them on a given product, especially if that information is presented in an engaging and clinically relevant way.

We do need to be more careful about leaders in academic medicine or health care organizations serving on the boards of directors of drug companies or being "virtually employed" by them through very lucrative consulting arrangements. There's just too much potential for conflicts of interest there.

What was it like to discuss these issues with colleagues while researching and writing this book? Did you face a lot of opposition from fellow doctors, or did you find that they were mostly supportive of your work?

Most doctors I know share my concerns about the failings of our current system of drug approval and marketing. I guess that means that physicians are generally enlightened about such things, or that I have a very narrow circle of colleagues.

What kind of ideas do you have for your future research? Do you plan tocontinue to try to promote pharmaceutical reform, or will you be turning your attention elsewhere?

I've "been into drugs" for my whole professional career. It's probably too late to change that, and that's fine with me. My future work will continue to focus on two major areas: developing and testing innovative ways to get accurate and unbiased drug information to prescribers, and using data from large health systems on drug use and outcomes to define adverse drug events as well as the cost-effectiveness of medications. With new products appearing so frequently, and new issues coming up about older drugs, this should keep me pretty busy for some time to come.